FDA.reportPublic FDA data

McKesson

Primary DI
00612479271753
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-DT16FRK
Device description
Suction Catheter kit 16FR (50/cs)
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYGSuction Catheter Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYGSuction Catheter KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479271753PackageGS150In Commercial Distribution
00612479271746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479271753006124792717536124792717530612479271753
00612479271746006124792717466124792717460612479271746

GMDN Terms#

Term, Definition table
TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479271647McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271661McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271685McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271708McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271722McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271746McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271760McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271784McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271807McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271821McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271845McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271869McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271883McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271906McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271654McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271678McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271692McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271715McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271739McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271777McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271791McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271814McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271838McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271852McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271876McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271890McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00612479271913McKessonMCKESSON MEDICAL-SURGICAL INC.PYG2024-09-09
00810094575595CuraplexBOUND TREE MEDICAL, LLCPYG2023-03-30
00810094575601CuraplexBOUND TREE MEDICAL, LLCPYG2023-03-30